COOLA BARE REPUBLIC CLEARSCREEN SPF30- avobenzone, homosalate, octisalate, octocrylene lotion 
COOLA, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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COOLA BARE REPUBLIC CLEARSCREEN SPF30 LOTION

Active ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 1.5%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

-after 80 minutes of swimming or sweating

-immediately after towel drying

-at least every 2 hours

-limit time in the sun, especially from 10 a.m.-2 p.m.

-wear long-sleeved shirts, pants, hats, and sunglasses

Other information

Inactive Ingredients

Behenyl Alcohol, Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Gluoside, Cetearyl Olivate, Chlorophenesin, Daucus Carota Sativa (Carrot) Seed Oil, Ethylhexylglycerin, Fragrance, Glycerin, Glyceryl Stearate, Neopentyl Glycol Diheptanoate, Polymethyl Methacrylate, Rubus Idaeus (Raspberry) Seed Oil, Sodium Hyaluronate, Sodium Hydroxide, Sodium Phytate, Sorbitan Olivate, Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopheryl (Vitamin E), Vitis Vinifera (Grape) Seed Oil, VP/Hexadecene Copolymer, Water, Xanthan Gum

Label

CA61484

COOLA BARE REPUBLIC CLEARSCREEN SPF30 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CARROT SEED OIL (UNII: 595AO13F11)  
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79753-013-71148 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2021
Labeler - COOLA, LLC (956990290)

Revised: 3/2021
Document Id: bcd2579d-f696-2459-e053-2a95a90abcff
Set id: bcd257d1-bb21-4249-e053-2995a90a9d97
Version: 1
Effective Time: 20210305
 
COOLA, LLC